Developing rapid sterility testing for cell and gene therapies

Bringing together the cross-sector expertise of commercial cell therapy developer, GSK, and leading technology provider, LGC, to develop a new approach to support in-process sterility and product release testing. 

The challenge

The current ‘gold standard’ compendial test for pharmaceutical sterility first appeared in the British Pharmacopeia in 1932 and has remained fundamentally unchanged ever since. The test requires a sample of a product to be placed into aerobic and anaerobic recovery media for a 14 day culture period during which no growth should be observed. This assay, while ideally suited for biopharmaceuticals, is not fit-for-purpose for cell and gene therapy products which are often formulated as drug products containing living cells with a shelf life of several hours to a few days.

Test first appeared in
1932and has since remained unchanged

Test requres
14 dayculture period

Test is not
fit-for-purpose for cell and gene therapy products

The project

This collaborative project is developing two complementary products. The first is being developed on the ParaDNA System, a rapid point-of-care testing platform designed and commercialised by LGC. The PCR/RT-PCR based test takes less than an hour to identify the presence of bacterial and fungal contamination, and is designed specifically so that non-scientific users can easily adopt the technology. An array of test formats already exists on this platform that aid users in rapidly screening wide variety of samples and sample types. A second approach is ultra-sensitive digital PCR assay which detects contamination down to single copy number and will be able to discriminate between contamination from live and dead microbes within complex gene therapy formulations. The digital PCR approach will support advanced raw-material and in-process testing allowing potential sources of microbial contamination to be identified which could cause false positive readouts in a rapid PCR product release assay.

Automated loading of the digital PCR microfluidics chip
Automated loading of the digital PCR microfluidics chip 

This project brings together the cross-sector expertise of two commercial cell therapy developers (GSK and Cell and Gene Therapy Catapult) and a leading technology provider (LGC) to develop a new approach to support in-process sterility and product release testing for a range of cell therapy products. 

Outputs

Project outputs will represent a significant step change to the established testing regimes with significant benefits to customers, to fulfil a critical current unmet need and supporting the development of real-time product release. For regulatory acceptance these assays will demonstrate comparability in sensitivity to the gold standard pharmacopeia compendial test and the sterility test that is currently used by GSK for their gene therapy product release. The comparability testing will be overseen by the regulatory affairs teams at Cell and Gene Therapy Catapult and GSK.

This project will provide a rapid alternative sterility method to meet a critical need for cell and gene therapy product developers for real-time process monitoring.

Lisa Wysocki, Microbiology Technical Lead, GSK

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